Minimal Sedation During Knee Replacement Surgery
This study is looking at whether using an Active Noise Cancelling Headset System with music or a movie can reduce the amount of sedation needed during total knee replacement surgery. This is for patients having a spinal anesthetic (localized anesthesia) instead of full sedation. Researchers will gather feedback from both patients and the surgical team. The study aims to see if this headset system can help lower the amount of Propofol (a sedative) used and improve patient comfort during the procedure. You may be eligible if you are 18 or older, need a primary total knee replacement, and can provide informed consent. The study is currently unclear on its recruitment status and plans to enroll 200 participants.
- Study design
- This is an interventional study planning to enroll 200 participants. It will test the use of an Active Noise Cancelling Headset System during surgery.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured intraoperatively (during surgery).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Minimal Sedation During Knee Replacement Surgery
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Matthew P Abdel, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mean Richmond Agitation-Sedation Scale(RASS) Score30 minutes intraoperatively
Richmond Agitation-Sedation Scale (RASS) measures the amount of sedation necessary for a patient at different levels of discomfort or agitation during local anesthesia surgeries.
- Protocol CompletionIntraoperatively
This will measure the volume of patients that were unable to complete their procedure using spinal anesthesia and due to discomfort or agitation required deep sedation to continue to surgery.
- Mean Propofol Infusion RateIntraoperatively
Mean rate of propofol infusion necessary to achieve sedation targets during the procedure. Unit: mcg/kg/min